FDA 510(k)

FLXfit

K-Number: K171519 · 2017-09-15

Decision Date2017-09-15

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

FLXfit is a medical device manufactured by Expanding Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-09-15 under approval number K171519. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLXfit?

FLXfit is a medical device that received FDA 510(k) clearance on 2017-09-15. It is manufactured by Expanding Orthopedics, Inc.. The 510(k) number is K171519.

When was FLXfit approved by the FDA?

FLXfit received FDA 510(k) clearance on 2017-09-15, under approval number K171519.

What company makes FLXfit?

FLXfit is manufactured by Expanding Orthopedics, Inc..

What is the FDA product code for FLXfit?

The FDA product code for FLXfit is MAX.

Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.